- Question
- Does lowering triglycerides with pemafibrate reduce cardiovascular events in patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia and low HDL cholesterol?
- Design
- Multinational, double-blind, randomized, placebo-controlled trial of 10497 patients with a median follow-up of 3.4 years.
- Population
- Patients with type 2 diabetes, triglycerides of 200 to 499 mg/dL, HDL cholesterol of 40 mg/dL or lower and LDL cholesterol of 100 mg/dL or lower, receiving guideline-directed lipid-lowering therapy or unable to take statins. 66.9% had previous cardiovascular disease.
- Intervention
- Pemafibrate 0.2-mg tablets twice daily.
- Control
- Matching placebo twice daily.
- Primary outcome
- Composite of nonfatal myocardial infarction, ischemic stroke, coronary revascularization, or cardiovascular death.
- Results
- The primary end point occurred in 572 patients with pemafibrate and 560 with placebo (HR 1.03; 95% CI 0.91 to 1.15). At 4 months triglycerides were 26.2% lower than with placebo, with no effect modification in any prespecified subgroup.
- Safety
- The overall incidence of serious adverse events did not differ significantly between groups; pemafibrate was associated with more adverse renal events and venous thromboembolism, and with fewer cases of nonalcoholic fatty liver disease.
- Conclusion
- Pemafibrate lowered triglycerides and other triglyceride-rich lipoproteins but did not reduce cardiovascular events compared with placebo.
- Why it matters
- It showed that lowering triglycerides with this drug alone does not translate into fewer cardiovascular events, questioning this strategy as a therapeutic target in this patient profile.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026